Armboard, Wheelchair
A Wheelchair Armboard is an extended arm support surface attached to the wheelchair to support the forearm and hand in a functional position, used in Physical Medicine for individuals with upper limb weakness, hemiplegia, or limited arm control. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IMY, regulated under 21 CFR 890.3910, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IMY
- Device Class
- FDA class 1
- Regulation Number
- 890.3910
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.